Exoskeletons for Spinal Cord Injury: A Feasibility Study

Phase

Condition

Spinal Cord Disorders

Spinal Cord Injuries

Treatment

N/A

Clinical Study ID

NCT01943669

13/EE/0048 (UK NRES)

Ages 18-55
All Genders

Study Summary

In this study, 10 volunteer participants with chronic spinal cord injury will undergo a 10-week training schedule for ambulation with the ReWalk™ device. The ReWalk™ consists of a lightweight brace-support suit containing motors at the hip and knee joints, rechargeable batteries and a computerized control system carried in a backpack. ReWalk™ users control their ambulation through subtle changes in centre of gravity and upper-body movements. Before, during and after training sessions the volunteers will perform standardised assessments and complete questionnaires to assess the functional and psychological effects of the exoskeleton. Functional outcomes primarily focus on ambulation outcomes and psychological outcomes primarily focus on predisposition and perceptions of disability. The outcomes of this pilot study will assist the investigators in the preparations of randomised controlled trail for assessing the efficacy of the ReWalk™ device in a neurorehabilitation setting.

Eligibility Criteria

Inclusion

Inclusion Criteria:

American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B & C (LowerExtremity Motor Score <20)
Motor level of injury from Cervical level 7 to Lumbar level 1, according to ASIAguidelines
Male and non-pregnant, non-lactating female
Age 18-55 years old
At least 12 months after injury
Able to stand or maintain upright position with or without using a standing device (e.g., 'Easy stand')
Able to sit with hips and knees ≥90° flexion
Height of 160 to 190 cm
Weight of <100 kg

Exclusion

Exclusion Criteria:

History of severe neurological injuries other than spinal cord injury (eg. MultipleSclerosis, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury,Stroke)
Concurrent medical diseases (eg. infections, circulatory, heart or lung, pressuresores) interfering with the study
Unstable spine or unhealed limbs or pelvic fractures
Limited range of motion (<90°) hip and knee joints, including severe contractures
Severe spasticity (Ashworth grade 4; ie. Affected part(s) rigid in flexion orextension) or uncontrolled clonus
Diagnosis of severe osteoporosis/penia as proven with pQCT or DXA.
Psychiatric or cognitive conditions that may interfere with the trial
Previous use of any exoskeletal robotic device
Patients incapable of providing informed consent

Study Design

June 01, 2013

December 31, 2013

Study Description

In this study, 10 volunteer participants with chronic spinal cord injury will undergo a 10-week training schedule for ambulation with the ReWalk™ device. The ReWalk™ consists of a lightweight brace-support suit containing motors at the hip and knee joints, rechargeable batteries and a computerized control system carried in a backpack. ReWalk™ users control their ambulation through subtle changes in centre of gravity and upper-body movements. Before, during and after training sessions the volunteers will perform standardised assessments and complete questionnaires to assess the functional and psychological effects of the exoskeleton. Twenty one-hour training sessions are scheduled for each participant over a 10-week period. Functional outcomes primarily focus on ambulation outcomes and psychological outcomes primarily focus on predisposition and perceptions of disability. The outcomes of this pilot study will assist the investigators in the preparations of randomised controlled trail for assessing the efficacy of the ReWalk™ device in a neurorehabilitation setting.

Connect with a study center

National Spinal Injuries Centre, Stoke Mandeville Hospital
Aylesbury, Buckinghamshire HP21 8AL
United Kingdom
Active - Recruiting

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